US11413332B2ActiveUtilityA1

Methods of using interleukin-10 for treating diseases and disorders

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Assignee: LILLY CO ELIPriority: Nov 11, 2013Filed: Nov 7, 2014Granted: Aug 16, 2022
Est. expiryNov 11, 2033(~7.3 yrs left)· nominal 20-yr term from priority
Inventors:John Brian MummIvan Ho ChanMartin Oft
A61K 39/3955A61K 47/10A61K 47/60A61K 45/06A61K 9/0021A61K 9/0019A61K 2300/00A61K 39/395A61K 38/2066A61P 35/00
57
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Cited by
442
References
20
Claims

Abstract

Methods of treating subjects having diseases, disorders, or conditions, including cancer and immune- and inflammatory-related disorders, via the administration of IL-10 in combination with one or more additional agents, and methods and models associated therewith, are provided.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method of treating cancer in a human, comprising administering to the human:
 a) a therapeutically effective amount of an inhibitor of at least one immune checkpoint, wherein the immune checkpoint inhibitor is an anti-PD-1 or anti-PD-L1 antibody, wherein the anti-PD-1 or anti-PD-L1 antibody is selected from the group consisting of nivolumab, lambrolizumab, atezolizumab, and durvalumab; and 
 b) a therapeutically effective amount of an IL-10 agent, wherein the IL-10 agent is a PEG-IL-10 agent, wherein the IL-10 component of the PEG-IL-10 agent comprises mature human IL-10, and wherein the PEG component of the PEG-IL-10 agent comprises at least one PEG molecule covalently attached to the alpha amino group of the amino acid residue at the N-terminus of IL-10, wherein the PEG component of the PEG-IL-10 agent has a molecular mass from about 5 kDa to about 20 kDa, and wherein the amount is sufficient to maintain a mean IL-10 serum trough concentration of at least 1.0 ng/mL; and 
 wherein the cancer is melanoma, lung cancer, or kidney cancer. 
 
     
     
       2. The method of  claim 1 , wherein the cancer is lung cancer. 
     
     
       3. The method of  claim 1 , wherein the cancer is kidney cancer. 
     
     
       4. The method of  claim 1 , wherein the PEG-IL-10 agent comprises a mixture of mono-pegylated and di-pegylated IL-10. 
     
     
       5. The method of  claim 1 , wherein the administering of the inhibitor of at least one immune checkpoint and the IL-10 agent is by parenteral injection. 
     
     
       6. The method of  claim 5 , wherein the administering of the IL-10 agent is by subcutaneous injection. 
     
     
       7. The method of  claim 1 , wherein the inhibitor of at least one immune checkpoint and the IL-10 agent are administered simultaneously. 
     
     
       8. The method of  claim 1 , wherein the inhibitor of at least one immune checkpoint and the IL-10 agent are administered sequentially. 
     
     
       9. The method of  claim 1 , further comprising administering at least one additional prophylactic or therapeutic agent. 
     
     
       10. The method of  claim 9 , wherein the prophylactic or therapeutic agent is a chemotherapeutic agent. 
     
     
       11. A method of treating cancer in a human, comprising administering to the human:
 a) a therapeutically effective amount of an inhibitor of at least one immune checkpoint, wherein the immune checkpoint inhibitor is an anti-PD-1 or anti-PD-L1 antibody, wherein the anti-PD-1 or anti-PD-L1 antibody is selected from the group consisting of nivolumab, lambrolizumab, atezolizumab, and durvalumab; and 
 b) a therapeutically effective amount of an IL-10 agent, wherein the IL-10 agent is a PEG-IL-10 agent, wherein the IL-10 component of the PEG-IL-10 agent comprises mature human IL-10, and wherein the PEG component of the PEG-IL-10 agent comprises at least one PEG molecule covalently attached to the alpha amino group of the amino acid residue at the N-terminus of IL-10, wherein the PEG component of the PEG-IL-10 agent has a molecular mass of about 5 kDa, and wherein the amount is sufficient to maintain a mean IL-10 serum trough concentration of at least 1.0 ng/mL; and 
 wherein the cancer is melanoma, lung cancer, or kidney cancer. 
 
     
     
       12. The method of  claim 11 , wherein the cancer is lung cancer. 
     
     
       13. The method of  claim 11 , wherein the cancer is kidney cancer. 
     
     
       14. The method of  claim 11 , wherein the PEG-IL-10 agent comprises a mixture of mono-pegylated and di-pegylated IL-10. 
     
     
       15. The method of  claim 11 , wherein the administering of the inhibitor of at least one immune checkpoint and the IL-10 agent is by parenteral injection. 
     
     
       16. The method of  claim 15 , wherein the administering of the IL-10 agent is by subcutaneous injection. 
     
     
       17. The method of  claim 11 , wherein the inhibitor of at least one immune checkpoint and the IL-10 agent are administered simultaneously. 
     
     
       18. The method of  claim 11 , wherein the inhibitor of at least one immune checkpoint and the IL-10 agent are administered sequentially. 
     
     
       19. The method of  claim 11 , further comprising administering at least one additional prophylactic or therapeutic agent. 
     
     
       20. The method of  claim 19 , wherein the prophylactic or therapeutic agent is a chemotherapeutic agent.

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